Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease

Last updated: December 10, 2020
Sponsor: Kala Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT02819284
KPI-121-C-007
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion

Exclusion Criteria:

  • Known hypersensitivity or contraindication to the investigational product(s) orcomponents
  • History of glaucoma, IOP>21 mmHg at the screening or randomization visits, or beingtreated for glaucoma in either eye.
  • Diagnosis of: ongoing ocular infection; severe/serious ocular condition that injudgment of Investigator could confound study assessments or limit compliance; or havebeen exposed to an investigational drug within 30 days prior to screening.
  • In the opinion of the Investigator or study coordinator, be unwilling or unable tocomply with study protocol or unable to successfully instill eye drops.

Study Design

Total Participants: 909
Study Start date:
June 01, 2016
Estimated Completion Date:
September 30, 2017

Study Description

This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Connect with a study center

  • UAB School of Optometry

    Birmingham, Alabama 35294-0010
    United States

    Site Not Available

  • Arizona Eye Center

    Chandler, Arizona 85225
    United States

    Site Not Available

  • NEA Baptist Clinic

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Sall Research Medical Center

    Artesia, California 90701
    United States

    Site Not Available

  • Milton M. Hom, OD, FAAO

    Azusa, California 91702
    United States

    Site Not Available

  • Family Eye Care Center

    Campbell, California 95008
    United States

    Site Not Available

  • Orange County Ophthalmology

    Garden Grove, California 92843
    United States

    Site Not Available

  • Lugene Eye Institute

    Glendale, California 91204
    United States

    Site Not Available

  • The Gavin Herbert Eye Institute

    Irvine, California 92697-4375
    United States

    Site Not Available

  • Advanced Vision Care

    Los Angeles, California 90067
    United States

    Site Not Available

  • Macy Eye Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • North Valley Eye Medical Group

    Mission Hills, California
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Arch Health Partners

    Poway, California 92064
    United States

    Site Not Available

  • Martel Eye Medical Group

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Shasta Eye Medical Group, Inc

    Redding, California 96002
    United States

    Site Not Available

  • West Coast Eye Care Associates

    San Diego, California 92115
    United States

    Site Not Available

  • Wolstan & Goldberg Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Michael K Tran, M.D., Inc.

    Westminster, California 92683
    United States

    Site Not Available

  • Hernando Eye Institute

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Central Florida Eye Associates

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Shettle Eye Research, Inc

    Largo, Florida 33773
    United States

    Site Not Available

  • International Eye Associates PA

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Fort Lauderdale Eye Institute

    Plantation, Florida 33324
    United States

    Site Not Available

  • Perez Eye Center/International Research Center

    Tampa, Florida 33603
    United States

    Site Not Available

  • Eye Care Centers Management, Inc. (Clayton Eye Center)

    Morrow, Georgia 30260
    United States

    Site Not Available

  • Chicago Cornea Consultants, Ltd.

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • John-Kenyon American Eye Institute

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Koffler Vision Group

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Taustine Eye Center

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • The Eye Care Institute

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Minnesota Eye Consultants, PA

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Tekwani Vision Center

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Tekwani Vision Center

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC

    Washington, Missouri 63090
    United States

    Site Not Available

  • Abrams Eye Institute

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Raymond Fong, MDPC

    New York, New York 10013
    United States

    Site Not Available

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Cornerstone Eye Care

    High Point, North Carolina 27262
    United States

    Site Not Available

  • James D Branch MD

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Comprehensive Eye Care of Central Ohio

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Drs. Fine, Hoffman & Sims, LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Medical Eye Center

    Medford, Oregon 97504
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Eye Care Specialists

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Bucci Laser Vision Institute

    Wilkes-Barre, Pennsylvania 18702
    United States

    Site Not Available

  • Chattanooga Eye Institute, P.C.

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Toyos Clinic

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Texan Eye, PA / Keystone Research, Ltd

    Austin, Texas 78731
    United States

    Site Not Available

  • The Cataract and Glaucoma Center

    El Paso, Texas 79902
    United States

    Site Not Available

  • Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center

    Houston, Texas 77034
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77024
    United States

    Site Not Available

  • The Ocular Surface Institute (TOSI), University of Houston

    Houston, Texas 77204
    United States

    Site Not Available

  • Whitsett Vision Group

    Houston, Texas 77055
    United States

    Site Not Available

  • Brazosport Eye Institute

    Lake Jackson, Texas 77566
    United States

    Site Not Available

  • Kozlovsky Delay & Winter Eye Consultants, LLC

    San Antonio, Texas 78230
    United States

    Site Not Available

  • Hoopes Vision

    Draper, Utah 84020
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

  • Regional Eye Associates

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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